Suturing apparatus and method

ABSTRACT

A suturing apparatus comprises a pair of jaws. A bendable needle housed in one of the jaws is adapted to carry a suture. A suture receiver is disposed adjacent to, or integral with, the opposite jaw to help disengage the suture carried by the bendable needle. A transition block curves the needle and directs it in a direction generally unparallel to an axis of the carrying jaw. The jaw housing the needle may include a lateral opening through which the suture may be inserted. The needle may also include a lateral notch which may be aligned with lateral opening to receive the suture. An actuator coupled to the needle enables the user to move the needle proximally to align the notch with the lateral slot.

RELATED APPLICATIONS

This application claims priority pursuant to 35 U.S.C. § 120 as adivisional of patent application Ser. No. 14/207,188, filed on Mar. 12,2014, which application is a continuation of patent application Ser. No.13/855,900, filed on Apr. 3, 2013, now issued as U.S. Pat. No.9,808,241, which application is a divisional of patent application Ser.No. 12/971,457, filed Dec. 17, 2010, now issued as U.S. Pat. No.8,540,732, which application is a divisional of U.S. patent applicationSer. No. 11/738,129, filed Apr. 20, 2007, now issued as U.S. Pat. No.7,879,046, which application is a continuation-in-part of U.S. patentapplication Ser. No. 10/255,523, filed Sep. 25, 2002, entitled “SUTURINGAPPARATUS AND METHOD,” now issued as U.S. Pat. No. 7,377,926, whichapplication relates to and claims priority pursuant to 35 U.S.C. §119(e) from U.S. Provisional Application Ser. No. 60/326,287, filed onOct. 1, 2001, entitled “SUTURING APPARATUS AND METHOD”, and also fromU.S. Provisional Application Ser. No. 60/358,960, filed on Feb. 25,2002, entitled “SUTURING APPARATUS WITH RETAINING MECHANISM.” Benefitsof priority of these applications, including the filing dates of Oct. 1,2001, Feb. 25, 2002, and Sep. 25, 2002, are hereby claimed, and theirdisclosures are hereby incorporated by reference as if fully set forthherein.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The invention relates generally to suturing devices and methods.

2. Description of Prior Art and Related Information

Suturing apparatus in the past have been required to have an elongateconfiguration and a low profile facilitating their use through cannulasin less invasive surgery. These devices have typically included opposingjaws which clamp on to the tissue to be sutured. Beyond this simpleclamping motion, typically facilitated by scissor handles, the mechanismfor threading a suture between the jaws and through the tissues havebeen exceedingly complex.

This complexity has derived primarily from the fact that the elongated,low profile configuration calls for an operating force that can betransmitted through an elongate tube. This force along the axis of theinstrument must then be converted into a force extending generallyperpendicular to the axis between the jaws. No simple structure has beendevised to accommodate this transition. Furthermore, loading a sutureonto a mechanism has also been complicated due to the complexity of thesuturing mechanisms.

SUMMARY OF THE INVENTION

In accordance with the present invention, structures and associatedmethods are disclosed which address these needs and overcome thedeficiencies of the prior art.

In one aspect, a suturing apparatus comprises a first jaw and a secondjaw movable with respect to each other. A bendable needle is carried bythe first jaw and adapted to carry a suture. The needle is movablebetween a first position wherein the needle is substantially housedwithin the jaw and a second position wherein a distal portion of theneedle protrudes from the first jaw. The apparatus further comprisesmeans for securing the suture in place prior to being carried by thebendable needle, and a suture receiver spaced apart from the first jawand configured to disengage the suture carried by the bendable needle.

The securing means may comprise a cantilevered spring included in adistal portion of the first jaw, a groove defined in a distal portion ofthe first jaw, a flap, or an elastomeric pad. The first jaw defines anaxis and further comprises a transition block adapted to guide thebendable needle in a direction substantially perpendicular to the axis.

In another aspect, a suturing apparatus comprises a first jaw definingan ingress, a second jaw movable with respect to the first jaw, and abendable needle carried by the first jaw and movable between a proximalposition and a distal position. The needle defines a needle slot thatmay be aligned with the ingress to enable loading of a suture throughthe ingress into the needle slot.

The apparatus further comprises a suture receiver which may be disposedadjacent to the second jaw, or integral with the second jaw. Theapparatus further comprises an actuator coupled to the bendable needleand configured for moving the bendable needle between the proximalposition and the distal position. The actuator preferably comprises athumb lever. The first jaw defines an axis and further comprises anaxial slot in communication with the ingress. The ingress may comprise alateral opening, and the needle slot may comprise a lateral slot.

A suture retrieving apparatus is also provided. The suture retrievingapparatus comprises a first jaw and a second jaw movable with respect toeach other, a suture receiver spaced apart from the first jaw, thesuture receiver being adapted to releasably retain a suture, and abendable needle carried by the first jaw. The bendable needle is movablebetween a proximal position and a distal position. The bendable needlehas a distal needle portion adapted to engage with the suture when thebendable needle is in the distal position. The distal needle portioncomprises a hook. The second jaw may comprise the suture receiver.

A method is provided for suturing a tissue. The method comprises thesteps of clamping a piece of tissue to be sutured, securing a suture inplace for engagement with a bendable needle, engaging a suture with abendable needle, carrying the suture toward a receiver with the bendableneedle, retaining the suture with the receiver, and retracting thebendable needle to release the suture.

The step of clamping a tissue to be sutured comprises the step ofcapturing the piece of tissue with a first jaw and a second jaw. Themethod further comprises the step of advancing the bendable needle in anaxial direction.

The step of carrying the suture toward a receiver with the bendableneedle comprises the step of bending the bendable needle, and moving atleast a portion of the bendable needle in a transverse direction.

A method is also provided for loading a suture onto a suturingapparatus. The method comprises the steps of housing a needle with aneedle slot in a first jaw, biasing the needle in a distal directionwith respect the first jaw so that the needle slot is not aligned withan ingress of the first jaw, aligning the needle slot with the ingress,disposing a suture through the ingress into the needle slot, andreleasing the biased needle such that the needle engages the suture andcarries the suture distally.

The step of aligning the needle slot with the ingress may comprise thestep of moving the needle either proximally or distally. The step ofmoving the needle proximally comprises moving the needle proximally witha finger slide. The step of disposing a suture through the ingress intothe needle slot comprises looping the suture about the ingress.

In summary, a suturing apparatus comprises a pair of jaws. A bendableneedle housed in one of the jaws is adapted to carry a suture toward asuture receiver disposed adjacent to the opposite jaw. A transitionblock curves the needle and directs it in a direction generally notparallel to an axis of the carrying jaw. The needle may also beconfigured to retrieve a suture. A retaining mechanism holds a suture inplace to be engaged by the needle. The jaw housing the needle mayinclude a lateral opening through which the suture may be inserted. Theneedle may also include a lateral notch which may be aligned withlateral opening to receive the suture. An actuator coupled to the needleenables the user to move the needle proximally to align the notch withthe lateral slot.

In another aspect, a suturing apparatus comprises a proximal handle andan elongated distal shaft having a distal end; a grasping mechanismpositioned adjacent to the distal end, the grasping mechanism includinga top jaw and a bottom jaw, at least one of the top jaw and the bottomjaw hinged to the shaft at a position proximal to the distal end, thegrasping mechanism operationally coupled to the handle for opening andclosing the top jaw and the bottom jaw with respect to one another atthe distal end; a slot extending vertically through the top jaw and thebottom jaw and extending proximally from the distal end to a slot endwithin at least one of the top jaw and the bottom jaw, the slot having aslot width tapering proximally toward the slot end for frictionallyretaining an intermediate portion of a length of suture; and a sutureneedle longitudinally positionable within and distally deployable fromthe shaft, the needle having a open-sided notch engageable with theintermediate portion of suture, for passing the suture when the needleis deployed from the shaft, the needle operationally coupled to thehandle for positioning and deployment.

In another aspect, a suturing apparatus comprises a ratchet that locksunless positive disabled. In a preferred embodiment, such a suturingapparatus comprises a proximal handle and an elongated distal shafthaving a distal end; a grasping mechanism positioned adjacent to thedistal end, the grasping mechanism including a top jaw and a bottom jaw,at least one of the top jaw and the bottom jaw hinged to the shaft at aposition proximal to the distal end for movement between an openposition and a closed position; a jaw movement mechanism thatoperationally couples the grasping mechanism to the handle for openingand closing the top jaw and the bottom jaw with respect to one anotherat the distal end; a spring that biases grasping mechanism to the openposition; and a ratchet latch assembly that prevents the jaw movementmechanism from moving toward the open position unless positive action istaken to disable the ratchet latch assembly.

In another aspect, a suturing apparatus comprises a needle movementmechanism that moves the needle distally when the needle movementmechanism is moved proximally. In a preferred embodiment, such asuturing apparatus comprises a bendable needle having a generally flat,narrow and elongate configuration, and a distal needle tip; a first jawdefining an axis and a needle channel that guides the bendable needlealong the needle channel to a channel exit; a second jaw movable withrespect to the first jaw for holding tissue to be sutured between thefirst and second jaws; the bendable needle reciprocally movable betweena proximal needle position where the needle tip is resting inside thefirst jaw and a distal needle position where the needle tip isprotruding from the first jaw; and a needle movement mechanismcomprising a needle trigger that reciprocally moves between a distaltrigger position and a proximal trigger position, the needle triggeroperatively connected to the bendable needle to move the bendable needledistally when the needle trigger is pulled proximally.

In another aspect, a suturing apparatus comprises a needle thatautomatically returns to a loading position. In a preferred embodiment,such a suturing apparatus comprises a handle assembly; an elongate shaftextending from a distal end of the handle assembly; a first jawextending distally from the elongate shaft, the first jaw having anaxis, a needle channel, a channel exit, and a suture loading ingress; asecond jaw movable with respect to the first jaw for holding tissue tobe sutured between the first and second jaws; a bendable needle having agenerally flat, narrow and elongate configuration, a distal needle tip,and an open-sided needle notch, the bendable needle reciprocally movablebetween a proximal needle position where the needle tip and open-sidedneedle notch are resting inside the first jaw and the suturing apparatusis ready for suture to be loaded into the first jaw via the sutureloading ingress and a distal needle position where the needle tip andopen-sided needle notch are protruding from the first jaw with thesuture loaded into the first jaw via the suture loading ingress locatedon an opposite side of the tissue in the open-sided needle notch; aneedle movement mechanism that reciprocally moves the needle distallyand proximally between the proximal needle position and the distalneedle position; and a spring that automatically returns the bendableneedle to the proximal needle position and readies the suturingapparatus for suture to be loaded into the first jaw via the sutureloading ingress.

In another aspect, a suturing apparatus comprises a means for loadingsuture in a single step. In a preferred embodiment, such a suturingapparatus comprises a handle assembly; an elongate shaft extendingdistally from the handle assembly; a first jaw extending distally fromthe elongate shaft, the first jaw having an axis, a top, a bottom, aneedle channel that runs along the first jaw's axis and around a curveto a channel exit, and a suture loading ingress that extends through thefirst jaw from the top to the bottom and leads to a suture channel thatalso extends through the first jaw from the top to the bottom, thesuture channel being in communication with and in substantial alignmentwith the needle channel; a second jaw movable with respect to the firstjaw for holding tissue to be sutured between the first and second jaws;a bendable needle having a generally flat, narrow and elongateconfiguration, a distal needle tip, and an open-sided needle notch, thebendable needle reciprocally movable between a proximal needle positionwhere the needle tip and open-sided needle notch are resting inside thefirst jaw and the suturing apparatus is ready for suture to be loadedinto the first jaw via the suture loading ingress and a distal needleposition where the needle tip and open-sided needle notch are protrudingfrom the first jaw with the suture loaded into the first jaw via thesuture loading ingress located on an opposite side of the tissue in theopen-sided needle notch; and means for retaining suture loaded into thefirst jaw via the suture loading ingress prior to deployment of thebendable needle, the suture being loaded into the first jaw in a singlestep without regard to the position of the bendable needle and itsopen-sided needle notch.

In yet another aspect, a novel suturing needle comprises a needle with aproximal end and a distal end, with at least a distal portion of theneedle formed from a bendable material having a generally flat, narrowand elongate configuration, and with a sharp needle tip located at adistal end of the distal portion; and a finger tab connected to thebendable needle at or near a proximal end of the needle for loading theneedle into the surgical suturing device.

In yet another aspect, a novel suturing needle comprises a needle with aproximal end and a distal end, with at least a distal portion of theneedle formed from a bendable material having a generally flat, narrowand elongate configuration, and with a sharp needle tip located at adistal end of the distal portion; and a lubricious coating applied to asurface of the needle to reduce a force required to slide the needleback and forth within the surgical suturing device or tissue to besutured.

In yet another aspect, a novel method for loading suture in a singlestep is provided for suturing a tissue. The method comprises loading thesuture into the suture channel via the suture loading ingress such thatthe protrudes from the top and bottom of the first jaw and extendsacross the needle channel; retaining the suture in the suture channelprior to deployment; and capturing the retained suture with the bendableneedle as the bendable needle is moved distally during deployment.

The invention, now having been briefly summarized, may be bettervisualized by turning to the following drawings wherein like elementsare referenced by like numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view of a first preferred embodiment of asuturing apparatus according to the invention;

FIG. 2 is a close-up view of the first preferred suturing apparatusshowing a bendable needle substantially housed within a lower jaw;

FIG. 3 is a close-up view of the first preferred suturing apparatusshowing the bendable needle piercing a piece of tissue;

FIG. 4 is a close-up view of the first preferred suturing apparatusremoved from the piece of tissue;

FIG. 5A is a perspective view of a jaw of the first preferred suturingapparatus housing the bendable needle;

FIG. 5B is a perspective view of the jaw of FIG. 5A showing the bendableneedle advanced to a distal, piercing position;

FIG. 6 is a front end view of the first preferred suturing apparatus;

FIG. 7A is an operative view illustrating a preferred suture receiverintercepting the suture carried by the needle;

FIG. 7B is a perspective view of the preferred suture receiver of FIG.7A retaining the suture after the needle is retracted;

FIG. 8A is an operative view of a further preferred suture receiver;

FIG. 8B is an operative of the preferred suture receiver of FIG. 8Aretaining the suture after the needle is retracted;

FIG. 9 is a front end view of a second preferred embodiment of a sutureapparatus comprising a suture retrieving device;

FIG. 10A is an operative view of the preferred suturing retrievingdevice of FIG. 9;

FIG. 10B is an operative view of the preferred suturing retrievingdevice showing a retrieving needle engaging a suture;

FIG. 10C is an operative view of the preferred suturing retrievingdevice showing the needle retrieving the suture;

FIG. 11 is a front end view of a third preferred suturing apparatuswherein a bendable needle is carried by an upper jaw;

FIG. 12 is a front end view of a fourth preferred suture retrievingapparatus wherein a bendable needle is carried by an upper jaw;

FIG. 13 is a perspective view of a fifth preferred suturing apparatusincluding a securing mechanism;

FIG. 14 is a front end view of the fifth suturing apparatus;

FIG. 15 is a side elevation view of the fifth suturing apparatus;

FIG. 16 is a close-up, perspective view of a suturing jaw incorporatingthe securing mechanism;

FIG. 17 is a top plan view of a tip of the suturing jaw of FIG. 16;

FIG. 18 is a perspective view of a suturing jaw incorporating analternative securing mechanism;

FIG. 19 is a close-up perspective of a suturing jaw incorporating afurther alternative securing mechanism;

FIG. 20 is a perspective view of the suturing jaw of FIG. 19;

FIG. 21 is a partially removed side elevation view of a sixth preferredsuturing apparatus;

FIG. 22 is a top plan view of a needle carrying jaw of the sixthpreferred suturing apparatus;

FIG. 23 is a perspective view of the needle carrying jaw of FIG. 22 witha bendable needle shown overlaid for clarity;

FIG. 24 is a perspective view of the needle carrying jaw with thebendable needle shown overlaid in an aligned position;

FIG. 25 is a perspective view of a handle assembly for the sixthpreferred suturing apparatus including a preferred needle actuator; and

FIG. 26 is a perspective view of the sixth preferred suturing apparatusbeing loaded with a suture;

FIG. 27 is perspective view of the sixth preferred suturing apparatuswith the suture loaded;

FIG. 28 is an elevation view of a preferred bendable needle according tothe invention;

FIG. 29 is a partially exploded, perspective view of a preferred suturereceiving mechanism;

FIG. 30 is a perspective view of the preferred suture receivingmechanism of FIG. 29;

FIG. 31 is a perspective view of a jaw comprising a single barb; and

FIG. 32 is a perspective view of a jaw comprising a pair of barbs;

FIG. 33 is a left side view of a suture passing apparatus according to aseventh and presently preferred embodiment;

FIG. 34 is a perspective view of a bendable needle for use with thesuture passing apparatus of FIG. 33;

FIG. 35 is a top plan view of the bendable needle of FIG. 34;

FIG. 36 is a left side view of the bendable needle of FIG. 34;

FIG. 37 is a perspective view of the suture passing apparatus of FIG. 33showing how the bendable needle of FIG. 34 is loaded therein;

FIG. 38 is an exploded perspective view of the suture passing apparatusof FIG. 33 and the bendable needle of FIG. 34;

FIG. 39 is a cross-section side view of the suture passing apparatus ofFIG. 33 with the bendable needle of FIG. 34 loaded therein;

FIG. 40 is a simplified cross-section side view that emphasizes thestructure and operation of the jaw movement mechanism;

FIG. 41 is a simplified cross-section side view that emphasizes thestructure and operation of the needle deployment mechanism;

FIG. 42 is an exploded perspective view of the fixed jaw at the distalend of the shaft of suture passing apparatus;

FIG. 43 is an enlarged close-up at the distal tip of FIG. 42;

FIG. 44 is an enlarged close-up corresponding to FIG. 43, but asassembled;

FIG. 45 is a top plan view of the fixed jaw at the distal end of theshaft of suture passing apparatus;

FIG. 46 is an enlarged close-up at the distal tip of FIG. 45;

FIG. 47 is side view of the fixed jaw at the distal end of the shaft ofsuture passing apparatus;

FIG. 48 is an enlarged close-up at the distal tip of FIG. 47; and

FIGS. 49a and 49b to 56a and 56b are successive pairs of a perspectiveand top plan view of the distal end of the preferred embodiment,respectively, illustrating the overall operation from the loading of thesuture through the end slot, the forward translation and momentarysideways movement of the needle as it engages the suture, the creationof a suture loop, and the retraction of the needle to the restingposition.

The invention and its various embodiments can now be better understoodby turning to the following detailed description wherein illustratedembodiments are described. It is to be expressly understood that theillustrated embodiments are set forth as examples and not by way oflimitations on the invention as ultimately defined in the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OFINVENTION

A first preferred embodiment of a suturing apparatus is illustrated inFIG. 1 and designated generally by the reference numeral 10. Theapparatus 10 is illustrated to have an elongate configuration with aproximal end 12 and a distal end 14. A handle assembly 16 is disposed atthe proximal end 12 and includes scissor handles 18 and 21 as well as anactuator 23. A pair of opposing jaws 25 and 27 are disposed at thedistal end and are coupled to the handle assembly 16 through an elongateshaft or tube 29. In one embodiment, the upper jaw 25 is pivotal withrespect to the lower jaw 27 as illustrated in FIG. 2.

In the illustrated embodiment the lower jaw 27 includes a needle 32 ofparticular interest to the present invention. In this case, the needle32 includes a body having a generally flat, narrow and elongateconfiguration. As shown in FIGS. 1-3, the needle 32 is formed from abendable material so that it can be moved generally with an axial forceprovided, for example, by a user's thumb, and can be bent on a curve,for example, to 90°, to move generally perpendicular to the axis andtoward the opposing upper jaw 25. It is to be expressly understood thatthe needle 32 can be substantially straight, as shown in FIG. 1, andthen be bent at any angle and advanced in any direction away from theaxis. The actuator 23, which preferably comprises a thumb rocker orslide, is coupled to the needle 32. The actuator 23 enables a user toadvance the needle 32 distally to a protruding, operative position andproximally to a retracted, inoperative position.

Threading this needle 32 with a suture 34 enables the needle to bedeployed through the tissue and to carry with it the suture 34 to bethreaded. The opposing jaw 25 may include an optional receiver which isadapted to remove the suture from the needle 32 as the needle 32 iswithdrawn back into the lower jaw 27. At this point, the suture extendsthrough the tissue and into the upper jaw. Removal of the jaws from thetissue, as illustrated in FIG. 4 permits withdrawal of the apparatus 10leaving the suture in place for tying or further manipulation. A suturereceiver is optional since the tissue itself may frequently serve as areceiver for the suture once the needle is retracted.

In this embodiment, the lower jaw is illustrated in FIG. 5A to includean elongate configuration and a channel 36 adapted to receive the needle32. The needle is bent at the distal end of this jaw 27 and up through atransition block 38 which aides in curving the needle 32 and directingit toward a suture receiver. Though the illustrated embodiment shows thetransition block 38 curving the needle 32 perpendicularly with respectto the axis of the lower jaw 27, the transition block 38 may beconfigured to curve and direct the needle 32 at any particular angle ordirection that is generally unparallel to the axis of the lower jaw 27.FIG. 5A shows the needle retracted and FIG. 5B shows the needle 32deployed and provided with a slot 40 to carry the suture 34 to theopposing jaw 25. This configuration is further illustrated in the radialcross-section view of FIG. 6.

In the upper jaw 25, a suture receiver 41 is provided to remove thesuture 34 from the needle 32. A metal or elastomeric flap, or paddle, 43is provided to engage the needle 32 and threaded suture 34 asillustrated in FIG. 7A. This flap 43 forces the suture 34 from theneedle slot 40 as the needle 32 is withdrawn as illustrated in FIG. 7.

In a similar embodiment, the needle 32 and threaded suture 34 is forcedthrough an elastomeric pad 45 which similar engages the suture 34 andremoves it from the needle slot 40 as the needle 32 is withdrawn asillustrated in FIG. 8B.

A second preferred embodiment of a suturing apparatus is illustrated inFIG. 9 which is a cross-section view similar to FIG. 6, but showing aneedle 32 which functions as a retriever rather than a carrier. In thisembodiment, the suture 34 is initially carried by the upper jaw 25. Aneedle slot 42 in this case extends distally from the side of the needle32. When this needle 32 and slot 42 are extended, as illustrated in FIG.10A, the slot 42 engages the suture 34 in the upper jaw 25. As theneedle 32 is withdrawn, the suture is retrieved in the needle slot 42and carried back through the tissue. The final step in this process isthe same as previously discussed with reference to FIG. 4.

It will be apparent that this apparatus 10 could also operate with theneedle 32 carried by the upper jaw 25. Such a feature is shown in athird preferred embodiment illustrated in the cross-sectional view ofFIG. 11 where the needle 32 functions as a suture carrier. Inparticular, a suture slot 40 defined in the needle 32 comprises anopening 50 that is located distally to an end 52 such that the slot 40faces the receiver, or lower jaw 27. A suture 34 is thus carried by theneedle 32 toward the opposing, lower jaw 27.

In FIG. 12, a fourth preferred embodiment of a suturing apparatuscomprises a suture retrieving device wherein the needle 32 is carried bythe upper jaw 25. In this case, the needle 32 functions as a retrieverof the suture 34. The needle 32 defines a slot 42 with an opening 54that is located proximally to an end 56 such that the slot 42 faces awayfrom the opposing, lower jaw 27. In the illustrated embodiment, a distalportion of the needle 32 is thus preferably shaped as a hook.

A fifth preferred embodiment of a suturing apparatus is illustrated inFIG. 13 and designated generally by the reference numeral 110. In FIGS.13-15, the apparatus 110 includes an elongate configuration with aproximal end 112 and a distal end 114. A handle assembly (not shown) isdisposed at the proximal end 112 and may include scissor handles whichare operatively coupled to a pair of opposing suturing jaws 116 and 118at the distal end 114. An elongate shaft or tube 121 couples the jaws116, 118 to the handle assembly. In one embodiment, the upper jaw 116 ispivotal with respect to the lower jaw 118 as illustrated in FIG. 13-15.

In the illustrated embodiment, the lower jaw 118 includes a retainingmechanism 123 of particular interest to the present invention. Theapparatus 110 may include a handle assembly, a bendable needle 125housed in one of the jaws 116,118, and a suture receiver included in theother of the jaws 116,118 as described above. Since the retainingmechanism 123 serves to securely hold a suture 127 while easilypermitting its release when engaged by the needle 125, the mechanism 123is preferably included in the jaw that houses the needle 125. Forexample, if the needle 125 is housed in the upper jaw 116, then theretaining mechanism 123 would also be included in the upper jaw 116.

A first preferred securing mechanism 123 comprises a spring 129 formedat a distal tip 132 of the jaw 118. The spring 129 includes a cantileverportion 134 bent back on itself. A wedge, or groove, 136 is definedbetween the cantilever portion 134 and an opposite wall 138 as shownmore clearly in FIGS. 16 and 17. In the illustrated embodiment of FIGS.13-16, the securing mechanism 123 is formed integrally with the jaw 118.To assemble the suture 127, a first end 141 is held beneath the jaw 118and the other end 143 above the jaw 118. The ends 141, 143 may be pulledin a proximal direction such that the suture 127 is wedged into thegroove 136. When disposed in the groove 136, the cantilever portion 134biases the suture 127 against the opposite wall 138, thus pinching thesuture 127 securely in place for engagement by the needle 125.

The biasing force of the spring 129 is configured such that the suture127 is both held securely absent engagement by the needle 125, and yetis permitted to be easily released upon engagement. It is to beexpressly understood, therefore, that the spring 129 may comprise avariety of mechanisms capable of abutting, or pinching, the suture 127against an opposing surface while permitting its release upon engagementwith a needle. The groove 136 is preferably aligned with or disposedadjacent to a needle exit port 145 such that when the ends 141, 143 aretugged proximally, a portion 147 of the suture 127 lies along the pathof the transversely extending needle 125.

In FIG. 18, a second preferred retaining mechanism 123 a may include aspring mechanism 129 a formed separately from the jaw 118 a. The springmechanism 129 a includes an anchor 149 configured to fit within a slot152 defined in the jaw 118 a.

In FIGS. 19 and 20, a third preferred retaining mechanism 123 bcomprises a zigzag groove 154 that becomes increasingly narrow as itextends proximally. The zigzag pattern in combination with the proximaltapering facilitates a tight fit when the suture 127 is drawnproximally. In particular, the proximally tapered configuration of thegroove 154 pinches the suture in place as it drawn proximally while thezigzag pattern prevents the suture 127 from being distally disengagedfrom the jaw 118 b.

A sixth embodiment of a suturing apparatus is shown in FIGS. 21-27 anddesignated generally by the reference numeral 210. The apparatus 210comprises a first jaw 220 and a second jaw 222 that are pivotal withrespect to each other. In FIGS. 21-23, the first jaw 220 is configuredto house a bendable needle 224. This needle carrying jaw 220 maycomprise either the lower or upper jaw of the apparatus 210. Thebendable needle 224 is substantially disposed in a channel 226 withinthe first jaw 220 when the needle 224 is in a non-operative, ornon-piercing, position.

In FIG. 22, the first jaw 220 defines an opening, or ingress 228, thatis in communication with an axial slot 231. The ingress 228 ispreferably provided with a relatively wide mouth 233 is open to one ofthe sides of the first jaw 220. This preferably lateral ingress 228tapers as it approaches the axial slot 231.

In FIG. 23, the needle 224 of particular interest to the invention isshown out of position, overlaying the first jaw 220 for clarity. Whenassembled, the needle 224 would reside in the channel 226 as discussedabove. The needle 224 comprises a lateral slot, or notch 235 (see FIG.28). An edge defining the notch 235 is preferably radiused, or smoothed,such it would not cut a suture. As best shown in original FIG. 28, theneedle 224 comprises distal portions that define a sharp needle tip 242,notch or slot portions that define the notch or slot 235 and itsassociated opening, and first and second void portions that define afirst distal crescent-shaped void 237 and an adjacent second proximalcrescent-shaped void 239. In the preferred needle of original FIG. 28,the distal portions that define the sharp needle tip 242 are equallybifurcated by the needle's axis. As further shown in FIG. 28, the slotportions defining the slot 235 define a base and a channel extendinglaterally of the base, the preferred base being configured as a circlewith a diameter that is greater than a width of the channel. The voids237, 239 collectively provide flexibility that is spread out on eitherside of the notch 235, over a greater length of the needle 224, suchthat all stresses do not collect at the notch 235 when the needle 224 isbent. The notch 235 is preferably disposed between the voids 237, 239.As further shown in original FIG. 28, the first void 237 is shaped likea crescent with a first radius and a first axial length and the secondvoid 239 is shaped like a crescent with a second radius greater than thefirst radius and with a second axial length greater than the first axiallength.

In a rest state, as shown in original FIG. 23, the needle 224 isgenerally straight and may be biased to any rest position with respectto the ingress 228. For example, the rest position may comprise thenotch 235 being disposed distally to the ingress 228, as shown in FIG.23, or proximally to the ingress 228. To load a suture, the needle 224is moved to a loading position whereby the notch 235 is aligned with theingress 228 as shown in FIG. 24. If the needle 224 is biased such thatthe notch 235 is distal to the ingress 228, alignment is reached bymoving the needle 224 in a proximal direction with respect to the firstjaw 220. Accordingly, if the needle 224 were biased such that the notch235 is proximal to the ingress 228, alignment is reached by moving theneedle 224 in a distal direction with respect to the first jaw 220. FIG.25 illustrates a preferred handle assembly 243 of the suturing apparatus210. In FIG. 25, a manually operable actuator 244 is coupled to theneedle to enable movement, proximally and distally, thereof. In theillustrated embodiment, the actuator 244 preferably comprises a thumblever, or rocker, that may be cocked backward by a user's thumb, therebymoving the needle proximally to align the notch with the ingress, andmoved forward, thereby advancing the needle distally.

FIG. 26 illustrates a suture 246 being loaded onto the apparatus 210.The suture 246 is formed into a loop and threaded into the ingress 228.With the suture 246 held slightly taut across the first jaw 220, thesuture 246 has entered the ingress 228 and is now disposed in the notchof the needle. The finger slide, shown in FIG. 25, may now be released,thereby distally biasing the needle with the captured suture 246 to theresting position as shown in FIG. 27. It will be appreciated that theaxial slot 231 of the first jaw 220 allows the captured suture 246 totravel freely as it is carried by the needle 224.

A transition block 248 is provided at a distal portion of the first jaw220 and may be integral with or separate from the jaw 220. Thetransition block 248 may be adapted to curve the needle and direct it atany desired angle, shown in the illustrated embodiment as generallyperpendicular to the axis of the first jaw 220.

In FIGS. 26 and 27, the second jaw 222 comprises a distal hook 251 thatdefines an aperture 253 with a side opening 255. When the jaws 220, 222are clamped on a piece of tissue, the aperture 253 is configured toenable the needle to pass through after piercing the tissue. As theneedle 224 is retracted the tissue acts as a suture receiver by holdingon to the suture 246 while the needle 224 is withdrawn. This leaves aloop or free line of suture 246 on the side of the tissue in contactwith the jaw 222. The hook 251 can then be placed in the loop andpulled. Alternatively, the two jaws 220, 222 can be grasped on the freeline of suture and pulled through the tissue. In FIG. 25, a stationaryfinger support 257 serves as a counterforce plate for the actuator 244.

In FIG. 28, the preferred bendable needle 224 comprises a distalgeometry that facilitates a smooth piercing of tissue by preventing thetissue from being snagged or caught by any part of the needle 224. Theneedle 224 comprises a notch side 259 and an opposite, void side 262. Inparticular, the needle 224 comprises a straight, notch-side edge 264located proximally to a notch edge defining the notch 235. The needle224 also defines a needle axis “A” that extends generally parallel tothe notch-side edge 264.

As the needle 224 pierces a tissue, the tissue will travel along anotch-side ramp 266 that leads to a distal ledge 268 disposed distallyof the notch edge defining the notch 235. As shown, a distal notch edgeextends from the base and laterally from the axis for a first distanceand a proximal notch edge that extends laterally from the base andlaterally from the axis for a second distance that is less than thefirst distance. It will be appreciated that the distal ledge 268 isspaced a transverse distance “B” from the axis “A” while a proximalledge 271 is spaced a transverse distance “C” from the axis “A.” In thepreferred embodiment, distance “B” is greater than distance “C” suchthat the distal ledge 268 pushes the pierced tissue outward to help keepthe tissue from getting caught in the notch 235. As the tissue travelsover the notch 235, a generally rounded bump that is associated with theproximal ledge 271 further prevents the tissue from getting snagged.

On the opposite, void side 262, first and second void edges define thefirst and second voids 237, 239 that distribute the stresses more evenlyacross the needle 224 and around the notch 235 when the needle 224 isbent, such that the stresses are minimized near the notch 235. Theopening to the notch 235 is directed distally such that the suture isforced into the needle during deployment through the tissue and so thatthe suture releases easily as the needle is retracted.

A further preferred embodiment of a suture receiver 280 is illustratedin FIGS. 29 and 30. The receiver 280 may, for example, be carried by ajaw opposite to the jaw housing a needle. The suture receiver 280comprises a pair of flaps, or paddles, 282 disposed in a receiverhousing 284. The paddles 282 are preferably configured to abut oneanother at a pinch point 286, as shown in FIG. 30, to permit a needle totravel therebetween while retaining a carried suture when the needle isretracted. As discussed above, employment of a suture receiver isoptional as the pierced tissue itself may often time serve as a suturereceiver. In particular, after a needle carrying a suture has piercedthe piece of tissue, the pierced tissue often times sufficiently retainsthe suture in the form of a loop as the needle is retracted.

In FIG. 31, a first preferred embodiment of a hook, or barb 291, isformed at the distal end of a jaw, preferably the second jaw opposite tothe first jaw housing the bendable needle. The barb 291 is configured tohook a looped suture that is retained, for example, by the tissue itselfafter the bendable has been retracted. In FIG. 32, a distal end of a jawmay alternatively be formed with a pair of barbs 293.

The above-described embodiments generally represent a significantadvance in the suture passing art because they permit suture to beretained in a device for delivery to a surgical site and in particularvia an arthroscopic cannula, permit the tissue to be grasped andre-grasped if necessary, and permit the suture to be pushed through thetissue with a reciprocating bendable needle. However, improvements arestill possible in terms of how the suture is loaded into the passer forcapture by the needle, the construction of the needle, and the overallsimplification of needle deployment.

FIGS. 33-48 relate to a new, seventh, and presently preferred embodimentthat adds a number of significant advancements.

FIG. 33 is a side view of a novel suture passing apparatus 310 and FIGS.34-36 show an improved bendable needle 400 for use with the suturepassing apparatus 310. As shown in FIG. 33, the suture passing apparatus310 generally comprises a handle assembly 320 located at a proximal end312, an elongate shaft 330 extending from the handle assembly 320, and agrasping mechanism formed by a pair of jaws 340, 350 supported at adistal end 314 of the elongate shaft 330 and a jaw movement mechanism360 and related ratchet latch assembly 370 (described more fully below).The preferred handle assembly 320 is formed from two halves, a left half321 and a right half 322 (not shown) held together by a plurality ofscrews 323, and the elongate shaft 330 is held between the two halveswith a handle-to-shaft pin 324 that engages a notch (not shown) at aproximal end of the shaft 330. The jaws include a fixed jaw 340 and amoveable jaw 350. The moveable jaw 350, as shown, is pivotally securedto a distal end of the shaft with a jaw-to-shaft pin 352.

As further shown in FIG. 33, and described more fully below, the novelsuture passing apparatus 310 includes two mechanisms, a jaw movementmechanism 360 (and related ratchet latch assembly 370) for opening andclosing the jaw assembly, and a needle movement mechanism 380 fortranslating the needle back and forth.

The jaw movement mechanism 360 opens and closes the moveable jaw 350 andis manipulated by way of a jaw trigger 361. The prior embodimentsrequired the surgeon to proactively move the jaw in both the open andclosed directions. For simplified use in this embodiment, the moveablejaw 350 is optionally biased open and then moved toward the closedposition relative to the fixed jaw 340 when the surgeon squeezes the jawtrigger 361. In addition, the jaw movement mechanism 360 may optionallyinclude a superelastic element that deforms under load to limit jawclosing force.

As already noted, the ratchet latch assembly 370 relates to the jawmovement mechanism 360. The preferred ratchet latch assembly 370 istransparent in its operational nature in that it locks without positiveaction by the user, but can be disabled with simple depression of arelease button, and all without the operator having to change his handposition. In particular, then the jaw trigger 361 is pulled, a movingportion 373 of the ratchet latch assembly 370 travels freely into thehandle assembly 320, but through a mechanical interaction more fullydescribed below, prevents the jaw trigger 361 from returning to an openposition until later released. For that purpose, the preferred ratchetlatch assembly 370 features a ratchet release or finger pad 371 suchthat the ratchet latch assembly 370 acts like a ratchet when no load isapplied to the finger pad 371, while a simple depression of the fingerpad 371 releases the ratchet latch assembly 370 and permits the surgeonto vary the position of the jaw trigger 361 and moveable jaw 350 asdesired (e.g. for repositioning the jaws as necessary prior to placementof the suture), and if permitted, to return to their open positions.

FIGS. 34-36 illustrate the bendable needle 400 that is intended for usewith the suture passing apparatus of FIG. 33. For referential purposesof, the needle 400 has a proximal end 412 and a distal end 414. Asshown, the needle 400 is formed from a proximal needle body 401 that hasa slotted distal end 402, and a flat bendable extension 403 that withinand is welded to the slotted distal end 402 of the needle body 401. Thedistal end 414 of the bendable needle 400 is similar to the previouslypreferred needle of FIG. 28 in that it has a needle tip 404, a needlenotch 405 on its side, and a notch-side ramp 406 between the tip 404 andthe notch 405. However, the presently preferred needle 400 uniquelycooperates with the suture passing apparatus for purposes of loading thesuture in a novel way (as described below), and it includes some novelconstruction features that make it easier to use and safer.

Focusing on the differences that constitute the novel construction forthe moment, one can see that the previously disclosed needle body had aright-angle bend at its proximal end that engaged an aperture in athumb-operated actuator (see e.g. FIG. 25), whereas the needle 400 mayinclude a plastic tab 406 at its proximal end 412 that functions as aproximal loading flag. The preferred plastic tab 406 is made of HDPE,polyethylene, and formed onto the needle body 401 in known manners, butany suitable material and or assembly method may be used.

The plastic tab 406 offers some unique advantages. First, it provides aconvenient finger grip for loading the bendable needle 400 into thesuture passer 310. In addition, it optionally melts upon autoclaving,thereby enhancing patient safety by effectively preventing reuse of theneedle 400.

FIG. 37 is a partially-exploded perspective view of the preferred suturepassing apparatus 310 and the bendable needle 400 that is loaded intothe suture passing apparatus. In particular, the dashed line shows howthe needle 400 is loaded into the breech or proximal end of the elongateshaft 330 via a chamber 325 located on a top side of the handle assembly320. As will be more fully described with reference to further figures,after the needle 400 is fully inserted into the elongated shaft 330, theloading flag 406 is pressed down into a needle receiver 390. The needlereceiver 390 is moved back and forth by the surgeon's manipulation ofthe needle trigger 381.

FIG. 38 is a fully-exploded perspective view of the preferred suturepassing apparatus 310 and the bendable needle 400. Here, one can see thedetailed construction of the preferred device, including the componentsof the jaw movement mechanism 360, ratchet latch assembly 370, andneedle movement mechanism 380. For ease of description, the foregoingmechanisms will be described with reference to FIGS. 39-41, which can bereviewed in conjunction with the fully-exploded perspective view of FIG.38.

FIGS. 39-41 are cross-section side views of the suturing apparatus 310and bendable needle 400 loaded therein. FIG. 39 is a full cross-section,whereas FIGS. 40 and 41 that selectively omit some of the othercomponents, or only shown them in broken line, in order to emphasize theconstruction and operation of the jaw movement and needle movementmechanisms, 360, 380, respectively.

FIG. 40 focuses on the jaw movement mechanism 360 and related ratchetlatch assembly 370 by showing much of the overall apparatus 310 inbroken lines and by strategically eliminating the components associatedwith the needle movement mechanism 380 (see FIG. 42). As shown, the jawmovement mechanism 360 comprises a jaw trigger 361, a jaw trigger pin362, a jaw trigger push rod 363, a jaw lever spring 364, a link 365, anactuator 368, and, lastly, the moveable jaw 350 itself. In operation,when the jaw trigger 361 is squeezed, it pivots about the jaw triggerpin 362 along arc J1, and the jaw trigger push rod 363 compresses thejaw lever spring 364 which, as noted earlier, tends to bias the jawtrigger 361, moveable jaw 350, and overall jaw motion mechanism 360 inthe open position.

As the jaw trigger 361 is moved along arc J1, an upper portion of thejaw trigger 362 is moved through a corresponding, but smaller radius arcJ2. In this vicinity, a trigger-to-link pin 366 connects the jaw trigger361 to the link 365, and further downstream, a link-to-actuator pin 367connects the link 365 to the actuator 368. Through this series ofconnections, the arcuate motion of the jaw trigger 361 along arcs J1 andJ2 is converted into translational movement of the actuator 368 alongarrow J3. As best shown by FIGS. 38, 39 and 40, the elongate shaft 330is provided with a plurality of guide pins 331, two from each side, andan actuator channel 333 that runs along its length. The actuator 368slides back and forth within shaft's actuator channel 333.

The actuator 368 is, in turn, connected to a lower portion of themoveable jaw 350 via an actuator-to-jaw pin 351 that is located slightlybelow the jaw-to-shaft pin 352 about which the moveable jaw 350 rotates.As such, when the jaw trigger 361 is squeezed along arc J1 the upperportion of the trigger 361 is moved along arc J2, the actuator 368 istranslated along arrow J3, the proximal end of the moveable jaw 350 isrotated along arc J4, and the distal end of the moveable jaw 350 isrotated along arc J5, i.e. moved toward a closed direction.

FIG. 40 also illustrates the preferred ratchet latch assembly 370 thatincludes a finger pad 371, a moving portion 373 having sloped teeth 374,and a separate fixed portion 377 that also has sloped teeth 378. Theratchet latch assembly also includes a ratchet latch spring 375 thatprovides a light spring force to bias sloped teeth 374 of the movingportion 373 against the sloped teeth 378 of the fixed portion 377. Theratchet latch assembly 370 prevents the jaw trigger 361, biased to theopened position by the jaw lever push rod 363 and jaw lever spring 364,from moving to the open position until desired. In particular, thesloping teeth 374 readily slide over the sloping teeth 378 when the jawtrigger is squeezed along arc J1 in a counterclockwise direction toclose the moveable jaw 350, but the teeth 374, 378 tend to lock togetherto prevent the jaw trigger 361 from returning in the clockwise directionand opening the moveable jaw 350. When the surgeon desires to open themoveable jaw 350, he simply depresses the finger pad 371 which rocks thesloped teeth on the moveable portion 373 away from the sloped teeth 378on the fixed portion 377. At that point, the jaw spring 365 tends toopen the jaw movement mechanism 360, as controlled by the surgeon'sfinger on the finger pad 371. A further beneficial aspect of the novelhandle mechanism is a “ratchet on demand” feature. In the preferredembodiment, this feature is provided by the placement of the ratchetbutton or finger pad 371 on an upper portion of the jaw trigger 361.This enables the surgeon to choose whether or not to use the lockingfeature by varying how he grips the handle with his fingers—squeezingthe jaw trigger 361 without depressing the finger pad 371 permits theratchet latch assembly 370 to naturally engage, whereas moving the jawtrigger 361 with light but continuous finger pressure on the finger pad371 enables a repeated opening and closing of the jaw 350 withoutengaging the ratchet latch assembly 370. In order to permit the surgeonto enable or disable the ratchet latch assembly as desired by varyingthe pressure applied to the finger pad 371 through the motion of the jawtrigger 361, the spring force of the ratchet latch spring 375 thataffects the finger pad 371 is much less than the spring force of the jawlever spring 364 that affects the overall jaw trigger 361.

FIG. 41 focuses on the needle movement mechanism 380 in the context ofthe overall apparatus 310 shown in broken lines and, in this case, bystrategically eliminating the components associated with the jawmovement mechanism 360 and ratchet latch assembly 370 (see FIG. 41). Asshown, the needle movement mechanism 380 comprises a needle trigger 381,a trigger rack 384, a needle spring 386, a gear 387, a needle rack 388having a needle receiver 390, and lastly, the needle 400. The needletrigger 381 is connected to the needle rack 384, as shown, by a capscrew 382 and a pin 384. Each of the gear racks 384, 388 includes acorresponding rack guide 385, 389, which provides a low surface-areacontact surface for ease of movement.

The needle spring 386 biases the needle in the non-deployed or restingstate, as shown in FIG. 41. In operation, as the trigger rack 384 istranslated toward the proximal end 312 of the device 310 along arrow N1(to the right), the gear 387 translates the needle rack 388 and needletoward the distal end 314 of the device 310 along arrow N2 (to theleft). When the needle 400 is translated toward the distal end 312, itmoves through a needle channel 343 in the fixed jaw 340 and ultimately,curves upward, where it temporarily extends from the lower, fixed jaw340 along arrow N3.

The needle spring 386 must provide sufficient spring force toautomatically retract the needle 400 when the needle trigger 381 isreleased. And, the surgeon must overcome this spring force when hesqueezes the needle trigger 381 to deploy the needle 400. It isdesirable, therefore, to reduce the required spring force to minimize oreven eliminate hand fatigue relating to repeated actuations. For thispurpose, the preferred needle 400 is coated with a lubricious coatingthat makes it easier to slide the needle 400 back and forth in thedevice 310 and within the patient's tissue. This lubricious coatingreduces the needle's coefficient of friction and thereby lowers thespring force needed to retract the needle 400. The use of a lubriciouscoating makes the suturing device 310 easier to use by reducing therequired spring force by about 20%. The preferred coating is a curedpolytetrafluoroethylene (PTFE) coating, but any other fluoropolymer orultra-low sheer solid would suffice. The needle 400 may be coated bysimply dipping it into a container of PTFE particles that have beensuspended in a suitable solvent (the solvent flashing off after theneedle is removed from the suspension and leaving behind the PTFEcoating). Preferably, however, the needle 400 is heat cured after beingcoated in order to melt the PTFE to itself and form a more abrasionresistant coating.

FIGS. 42-48 collectively focus on the unique construction of the sutureloading and deployment arrangement as embodied in the novel suturingapparatus' lower jaw 340. As shown throughout FIGS. 42-48, the lower orfixed jaw 340 is located at a distal end of the elongated shaft 330. Inthis preferred embodiment, the fixed jaw 340 is formed from a lower jawbody 341 that is integrally formed from the same stock as the elongateshaft 330, in combination with a jaw insert 342 that is generally shapedlike a ski tip. During assembly, the jaw insert 342 is dropped into andsecured to the lower jaw body 341 in any suitable manner, e.g. welding.

The jaw insert 342 helps define a needle channel 343 which guides theneedle 400 forward and then up and out during deployment. In particular,as best understood by viewing FIG. 43, and then FIGS. 44 and 48, the jawinsert 342 ultimately rests on and spans a pair of ledges 349 (only oneis visible) that surrounds the floor and side walls of the needlechannel 343 already formed in the lower jaw body. In essence, the bottomof the jaw insert 342 serves as the ceiling of the needle channel 343.As explained in more detail below, the needle 400 (not shown in FIGS.42-48) is translated horizontally through the needle channel 343 whichincludes a curve that directs the needle upward toward and ultimatelyout of channel exit 344.

FIGS. 42-48 also illustrate a unique construction that relates to theinitial loading of the suture (not shown). In particular, the lower jaw340 has a forked distal end 345 that includes a suture loading ingressprovided as an end slot 346 that leads to a suture slot 347 contained inboth the lower jaw body 341 and jaw insert 342. The suture slot 347proximally terminates at a proximal suture retention node or slot end348 where the suture resides, as further detailed below, prior todeployment when the suture is picked up by the needle and a loop of thesuture is passed through the tissue held between the jaws.

In this embodiment, as best shown in FIGS. 44 and 46, the suture slot 37has varying dimensions along its length in order to provide frictionwithin portions of the slot relative to the suture to be deployed. Assuch, these dimensions vary relative to the suture to be passed by thedevice 310. The presently preferred device is intended for use with arange of suture, from #2 suture to #2-0 suture. The thicker #2 suturehas a nominal diameter of about 0.5 mm, or about 0.0196″, and thethinner #2-0 suture has a nominal diameter of about 0.3 mm, or about0.0118″. All further dimensions will be in inches. While this embodimentcan accommodate a particular range of suture sizes, e.g., #2 to #2-0suture, the dimensions can be adjusted as needed to accommodate anyconventional suture size or range of conventional suture sizes.

Although this is an exemplary embodiment and the principals of theunderlying invention can be varied to accommodate different size suture,a detailed review of this embodiment's dimensions may be helpful to thereader. At location “a” near the suture loading ingress or end slot 346,the width is much larger than the diameter of the suture so that thesuture is easily pulled into the end slot 346 and down into the sutureslot 347. At location “b” which extends on either side of the verticalportion of needle channel 343, the width is 0.024±001 such that the #2suture may continue to pass freely through this portion of the suturechannel 347. At location “c,” the width of the suture channel 347narrows to 0.020±001 such that the channel begins to closely conform tothe suture's nominal diameter. At locations labeled “d,” the suturechannel 347 narrows further to 0.019±001 such that there is a frictionfit between the channel 347 and the suture. And finally, when the sutureis pulled allows to the end of the suture channel 347 and into itsproximal suture retention node 348, the width expands to 0.026±001,thereby allowing the surgeon to make vertical adjustments to the sutureas desired prior to deployment to the surgical site. Generally, thesurgeon will leave a relatively short tag of suture extending below theunderside of the lower jaw 340 such that, after the device passes a loopof suture through the tissue, only that amount of suture need be pulledthrough the tissue by subsequently pulling on the loop before a singlestrand of suture remains. Moreover, after the device 310 is retractedfrom the surgical site, it is immediately ready to be reloaded withsuture because the needle spring 386, shown in FIG. 41 and describedabove, automatically retracts the needle to the non-deployed or restingstate and biases it in that position, whereby a new suture can beloaded.

FIGS. 49a and b to 56a and b are a succession of paired figures thatillustrate some structural nuances and overall operation of thepreferred embodiment. In particular, these figures show the overalloperation—all the way from the loading of the suture through the sutureloading ingress or end slot, the forward translation and momentarysideways movement of the needle as it engages the suture, the creationof a suture loop passed through the target tissue (the tissue has beenomitted for clarity), and the retraction of the needle to the restingposition.

FIGS. 49a and b show the position of the needle 400 relative to thesuture slot 347 and proximal suture retention node 348 when the needle400 is in the retracted or resting state.

FIGS. 50a and b show a length of suture 34 being initially pulledthrough the end slot 346 and down into the suture slot 347. Normally,the moveable jaw 350 would be closed prior to the loading of the suture34, or at least prior to introduction of the device 310 to the surgicalsite, but here the moveable jaw 350 is consistently shown in the openposition order to simplify the view.

FIGS. 51a and b show the suture 34 pulled a bit deeper into the sutureslot 347. At this junction, in this particular embodiment, the suture 34is being pulled into that part of the suture slot 347 that takes anon-linear path and that begins to narrow (see FIGS. 44 and 46 andrelated description). This geometry, or equivalent, provides sufficientfriction to keep the suture in the suture slot 347 during deployment.

FIGS. 52a and b show the suture 34 at the point where it has been fullyloaded into the proximal suture retention node 348 at the end of thesuture slot 347. In this embodiment, as can best be seen by looking backand forth between FIGS. 51b and 52b , the non-linear geometry of thesuture slot 347 also causes the needle tip 404 to be laterally tuckedoff to the side of the suture slot 347 so that the suture 34 does nothang up on the tip 404 when being pulled toward the proximal end of thesuture slot 347. This arrangement beneficially prevents the suture 34from being nicked as it is loaded. Also, as best shown in FIG. 52b ,after the suture 34 is safely located proximally to the needle tip 404,the sideward or lateral deflection of the needle provides a subtlespring force that is directed to the right (upward in the figure). Thissqueezes the suture 34 between the needle's notch-side ramp 406 and theopposite of the proximal suture retention node 348, thereby helpingretain the suture in place prior to placement without any further actionby the surgeon. The foregoing arrangement constitutes a means forretaining the suture 34 within the suture slot 347 prior to deployment.Other suitable structure may be used to accomplish this retentionfunction, of course, including, but not limited to squeezing or pinchingarrangements, friction based arrangements, a close relationship betweenthe diameter of the suture and the dimensions of the suture slot, etc.

Continuing with the remaining FIGS. 53-56, please note that tissue wouldordinarily be clamped between the lower jaw 340 and the moveable jaw 350prior to and during deployment of the needle 400 and placement of thesuture 34. In other words, during needle deployment, the moveable jaw350 would ordinarily be partially closed, as opposed to fully open asshown. However, in order to keep FIGS. 53-56 similar to FIGS. 49-52 andclarify what is shown, the tissue is omitted and the moveable jaw 350 inshown in the fully open position.

FIGS. 53a and b show the position of the needle 400 relative to thelower jaw 340, suture slot 347, and suture 34, as the needle 400 istranslated forward to the distal end of the device with the needletrigger 381 (see FIG. 41). As shown in FIG. 53b , the suture channel 343(see also the side view in FIG. 48) includes a deflection relief 349that permits the needle 400 to deflect to the left as it slides forwardpast the suture 34.

FIGS. 54a and b show the position of the various components after theneedle 400 has been moved forward to the point that its needle notch 405is aligned with the proximal suture retention node 348 and anintermediate portion of the suture 34 contained therein. By this point,a notch-side ramp 406 of the needle has cleared the suture 34 such thatthe needle 400 snaps back in line or springs back to the right and theintermediate portion of the suture 34 is surrounded by or captured inthe needle notch 405.

FIGS. 55a and b shows the system after the needle 400 and needle notch405 has been bent around the curve of the lower jaw's needle channel343, thereby carrying a loop of the suture 34 out of the needle exit 344of the lower jaw 340. If tissue were held between the lower and upperjaws 340, 350, then this loop of suture 343 would have been pushed orpassed through that tissue.

FIGS. 56a and b , lastly, shows the needle 400 after it hasautomatically returned to its internal resting state within the needlechannel 343 of the lower jaw 340. In this position, i.e. after passingthe suture, the overall suture passing device 310 can be simply pulledproximally away from the surgical site, the loop of suture 340 slidingout of the end slot 346 at the distal end of the device 310. The jaws340, 350 of the suture passing device 310, or a separate set of forceps,can then be used to pull the loop of suture 34 through the tissue. Notethat the device 310, if desired by the surgeon, is automatically readyto load another length of suture 34 into the end slot 346 for furthersuture passing activity.

In all embodiments, it is to be expressly understood that a disposableneedle may be employed. It will be appreciated, therefore, that a systemor kit is provided wherein the suturing apparatus (excluding the needle)may be re-used while the disposable needles are replaced.

Many alterations and modifications may be made by those having ordinaryskill in the art without departing from the spirit and scope of theinvention. Therefore, it must be understood that the illustratedembodiments have been set forth only for the purposes of examples andthat they should not be taken as limiting the invention as defined bythe following claims. For example, notwithstanding the fact that theelements of a claim are set forth below in a certain combination, itmust be expressly understood that the invention includes othercombinations of fewer, more or different ones of the disclosed elements.

The words used in this specification to describe the invention and itsvarious embodiments are to be understood not only in the sense of theircommonly defined meanings, but to include by special definition in thisspecification the generic structure, material or acts of which theyrepresent a single species.

The definitions of the words or elements of the following claims are,therefore, defined in this specification to not only include thecombination of elements which are literally set forth. In this sense itis therefore contemplated that an equivalent substitution of two or moreelements may be made for any one of the elements in the claims below orthat a single element may be substituted for two or more elements in aclaim. Although elements may be described above as acting in certaincombinations and even initially claimed as such, it is to be expresslyunderstood that one or more elements from a claimed combination can insome cases be excised from the combination and that the claimedcombination may be directed to a subcombination or variation of asubcombination.

Insubstantial changes from the claimed subject matter as viewed by aperson with ordinary skill in the art, now known or later devised, areexpressly contemplated as being equivalently within the scope of theclaims. Therefore, obvious substitutions now or later known to one withordinary skill in the art are defined to be within the scope of thedefined elements.

The claims are thus to be understood to include what is specificallyillustrated and described above, what is conceptually equivalent, whatcan be obviously substituted and also what incorporates the essentialidea of the invention.

What is claimed is:
 1. A suturing apparatus, comprising: a first jawdefining an ingress; a second jaw movable with respect to the first jaw;a bendable needle carried by the first jaw and movable between aproximal position and a distal position, the needle defining a needleslot that aligns with the ingress to enable loading of a suture throughthe ingress into the needle slot; and wherein the second jaw furthercomprises an integral suture receiver, the suture receiver comprising aflap in the second jaw, wherein the flap is removable from the secondjaw.
 2. A suturing apparatus, comprising: a first jaw and a second jawmovable with respect to each other; a bendable needle carried by thefirst jaw and adapted to carry a suture, the needle being movablebetween a first position wherein the needle is substantially housedwithin the first jaw and a second position wherein a distal portion ofthe needle protrudes from the first jaw; means for securing the suturein place prior to being carried by the bendable needle; and a suturereceiver disposed adjacent to the second jaw and configured to disengagethe suture carried by the bendable needle, the suture receivercomprising a flap in the second jaw, wherein the flap is removable fromthe second jaw.
 3. The apparatus of claim 2, wherein the suture receivercomprises a flap elastically deformable by the needle as it moves to thesecond position.
 4. The apparatus of claim 3, wherein the flapdisengages the suture carried by the bendable needle by returning to itsnon-deformed state as the needle is moved back to its first position. 5.A suturing apparatus, comprising: a first jaw defining an ingress; asecond jaw movable with respect to the first jaw; a bendable needlecarried by the first jaw and movable between a proximal position and adistal position, the needle defining a needle slot that aligns with theingress to enable loading of a suture through the ingress into theneedle slot; and a suture receiver disposed adjacent to the second jaw,the suture receiver comprising a flap, wherein the flap is removable. 6.The apparatus of claim 5, wherein the flap is elastic.